Work

Intravitreal Stivant® (a biosimilar to bevacizumab) alone versus combined with triamcinolone in center-involved diabetic macular edema

Year: 2025

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: Purpose To compare the effects of intravitreal Stivant® (a biosimilar to bevacizumab) alone and in combination with triamcinolone acetonide in center-involved diabetic macular edema (DME). Methods In this randomized controlled study, patients with center-involved DME (central macular thickness [CMT] > 300 µm) were assigned to receive either intravitreal Stivant® 1.25 mg alone (IVS group) or in combination with triamcinolone acetonide 1 mg (IVST group). The regimen consisted of injections every 4 weeks, administered three times. Changes in best-corrected visual acuity (BCVA) and CMT from baseline to follow-up visits were compared between the groups. Results Of the 140 enrolled participants, 70 eyes of 70 patients were assigned to each group. By week 12, both groups showed improvements in BCVA and CMT compared to baseline values ( P s < 0.001). BCVA (in logarithm of the minimum angle of resolution [logMAR] scale) improved more in the IVST group (0.75 ± 0.62 logMAR) compared to the IVS group (0.92 ± 0.93 logMAR, P < 0.001) at week 4. However, by week 12, BCVA did not differ between the two groups ( P = 0.089). Similarly, although the IVST group demonstrated a higher reduction in mean CMT (-143.40 ± 58.28 µm) compared to the IVS group (-92.19 ± 52.31 µm, P < 0.001) at week 4, this effect did not persist at the next follow-up visits. Conclusion In eyes with center-involved DME, IVST is more effective in reducing CMT and improving BCVA than IVS up to 1 month, but this superiority does not persist over time.

Source: JFO Open Ophthalmology

DOI: 10.1016/j.jfop.2025.100173